Check-MM
by Intl. Immunoassay Laboratories, Inc. 510(k)
Active
510(k) K883223
Overview
Check-MM is a differential rate kinetic method device used for the measurement of Cpk or isoenzymes. It functions within the clinical chemistry specialty to provide diagnostic analysis.
This device is regulated under FDA 510(k) clearance K883223. It is manufactured by Intl. Immunoassay Laboratories, Inc. and is classified as a class 2 medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883223 | Date30 Sep 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JHS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Intl. Immunoassay Laboratories, Inc.
Questions
What is the primary function of the Check-MM device?
The Check-MM is a clinical chemistry device designed to perform differential rate kinetic measurements of Cpk or isoenzymes to assist in diagnostic analysis.
What is the regulatory status of this device?
This device is classified as a class 2 medical device and has received FDA 510(k) clearance under the number K883223, indicating it has been found substantially equivalent to legally marketed predicate devices.
Which medical specialty is this device intended for?
The Check-MM device is categorized under the clinical chemistry specialty, which focuses on the analysis of bodily fluids to support clinical diagnostics.